FDA 510(k) Application Details - K031068

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K031068
Device Name Light, Surgical, Ceiling Mounted
Applicant Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
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Contact MELISSA MURPHY
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 04/04/2003
Decision Date 08/12/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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